The purpose of this FOA is to establish a consortium of tuberculosis (TB) preclinical and clinical experts to systematically refine preclinical models by analyses of relevant pre-clinical and clinical data, and to provide results from optimized models to identify the most efficacious combination regimens for future clinical testing through model-informed research.
Donor Name: National Institutes of Health
State: All States
County: All Counties
Territory: American Samoa, Commonwealth of Puerto Rico, Commonwealth of the Northern Mariana Islands, Guam, and U.S. Virgin Islands
Type of Grant: Grant
Deadline: 02/07/2023
Size of the Grant: $7.2 million
Grant Duration: 5 years
Details:
The proposed Consortium would establish a collaborative, multidisciplinary research platform to systematically evaluate new candidate agents in combination. These agents may originate from academic, public-private partnerships, and pharmaceutical industry research efforts and will be evaluated for their potential for incorporation into new TB drug regimens across the human lifespan including young children. By generating adequate and comparable preclinical data on regimen efficacy, pharmacometrics, toxicities, drug-drug interactions, and other factors essential for human clinical trials, the consortium will increase efficiency, accelerate development of new combinations, and identify the most promising regimens for future clinical testing to effect shorter, relapse-free cures of pulmonary TB in adults, children, and persons being treated for HIV.
The TB Drug Regimen Consortium aims to address this by:
- Providing an open platform for uniting preclinical and clinical TB experts (U.S. and international) in the systematic analysis of available preclinical and clinical efficacy and safety data to identify preclinical research projects, scientific needs/gaps and set an agenda of cooperative goals and research priorities.
- Optimizing preclinical models with back-translation of clinical data from recent trials into animal and other model development.
- Facilitating communication, coordination and planning of preclinical research to inform NIH-supported clinical trial networks (both adult and pediatric focused) and other sponsors/investigators by review and discussion of all available information on new agents/combinations, and ongoing and anticipated research. These discussions will guide plans for optimized drug combinations, eliminate duplication, and ensure efficiency by identification and, when appropriate, performance of key preclinical experiments by the Consortium’s Preclinical Laboratories.
- Incorporating pediatric-focused research to stimulate pre-clinical, translational activities that can enable accelerated clinical testing and earlier introduction of new TB drugs and regimens in pediatric populations, with an emphasis on young children (aged 6 years or younger).
- Performing preclinical evaluations of mechanisms of action of individual and combination drug candidates. Performing preclinical animal model studies (with emphasis on new drug combination efficacy comparisons) identified as needed by the Consortium leadership executive committee after review and approval by NIAID.
- Providing compiled data and analyses on evaluated combination regimens with priority ranking assessment for consideration by clinical trial networks to guide optimized and coordinated choices of new regimens for phase 2 and 3 trials.
- Assessing evolving clinical research challenges and opportunities for potential inclusion of special populations, new technologies (including biomarkers), and the broader spectrum of TB disease into the Consortium research agenda.
Funding Information
- NIAID intends to commit $7.2 million in FY 2024 to fund one award.
- The total project period may not exceed five years.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.
